MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER MODEL HBF 140; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number 00175

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012 at (b)(6), it was reported that three (3) units of the arterial filter quart 00175 leaked.The first one was used during the bypass procedure because there was not enough time to change it.The second one was noticed to be leaking along the top joint during priming and was replaced.The third filter was used during bypass surgery even though it was leaking.There was no patient impact.Note: two additional medwatches will be submitted to capture the first and second events for leaking.Reference mdr's 8010762-2014-00416 and 8010762-2014-01074.Reference: (b)(4).

Manufacturer Narrative

(b)(4).Per the final statement to the complaint letter dated april 17, 2012 leakage testing was performed on the returned sample and it was confirmed that there was a leak in the welding cover near the red stop cock.Such leakages would be clearly detected in the 100% function test in production, however it is possible that the leak could appear later on due to inner stress in the material.Reference: (b)(4).

• Brand Name: QUART ARTERIAL FILTER MODEL HBF 140
• Type of Device: FILTER, BLOOD, CPB, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; maquet medical system, usa; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4283039
• MDR Text Key: 5224077
• Report Number: 8010762-2014-01075
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2012
• Device Model Number: 00175
• Device Catalogue Number: 70000.0175
• Device Lot Number: 70074767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2012
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2012
• Initial Date Manufacturer Received: 03/01/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1